Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation



Status:Terminated
Conditions:Smoking Cessation, Tobacco Consumers
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 60
Updated:5/19/2016
Start Date:December 2013
End Date:June 2015

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Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation

Electronic cigarettes have shown promise but have yet to proven effective for smoking
cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers
who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The
investigators hypothesize that electronic cigarettes will be comparable to the nicotine
inhaler in terms of smoking cessation.

Cigarette smoking remains the leading cause of preventable death and disease worldwide.

The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for
smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.

Inclusion Criteria:

- 18-60 year old

- Meet DSM-IV criteria for nicotine dependence

- Seeking treatment for smoking cessation

- Smoking at least 15 cigarettes per day

- Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and
bipolar disorder or current diagnosis of major depressive disorder

- Current DSM-IV criteria for any other psychiatric disorder that may, according to the
investigator's judgment, require either pharmacological or non- pharmacological
intervention over the course of the study

- Currently receiving any treatment for nicotine dependence, including nicotine
replacement therapy

- Pregnancy, lactation, or failure to use adequate contraception methods in women who
are currently having sex with men

- Unstable medical condition, such as uncontrolled hypertension, angina, and
oropharyngeal conditions which may make participation hazardous

- Current DSM-IV diagnosis of substance dependence, other than nicotine

- Use of cannabis or alcohol on more than 20 days in the past 30 days

- Risk for suicide
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